NCT02178293CompletedPhase 4
MISTRAL (Mouthwash In Sore Throat Relief: Antiinflammatory vs. Local Anesthetic Therapy) "Efficacy and Tolerability of Ketoprofen Lysine Salt as a Mouthwash in Acute Phlogosis of the Pharyngeal Cavity; Multicentre, Randomized, Single-blind, Parallel-group Comparison Versus Benzidamine Hydrochloride"
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 214
- Primary Endpoint
- Duration of analgesic effects in hours
Study Overview
Brief Summary
A study to in order to verify any differences between the 2 treatment groups in terms of duration of analgesic effects after the first drug intake and time to remission of symptoms and signs of pharyngitis
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male and female outpatients, aged 18 to 70 years, suffering from acute pharyngitis, pharyngolaryngitis
- •Moderately or severely intense pain in the pharyngeal region (score ≥ 70 mm) from the "visual analogue scale" (VAS)
- •At least 1 of the 2 inflammation signs (edema and hyperemia) to be moderately or severely intense (score ≥ 2) from the scoring scale from 0 to 3
- •Release of written informed consent by the patient
Exclusion Criteria
- •Patients suffering from a microbial infection requiring specific antimicrobial treatment
- •Patients who have taken the trial drugs during the week before enrolment
- •Patients who have taken corticosteroids or antibiotics during the week before enrolment
- •Ascertained or suspected hypersensitivity to trial drugs or to chemically correlated drugs or to other non-steroidal anti-inflammatory drugs or to mouthwashes in general
- •Patients who are unable to properly fill in the diary every day as provided for by the protocol
- •Ascertained or presumed pregnant or lactating women
- •Inclusion in any other clinical trial during the study
Arms & Interventions
Benzidamine hydrochloride
Active Comparator
Intervention: Benzidamine hydrochloride (Drug)
Ketoprofen lysine salt
Experimental
Intervention: Ketoprofen lysine salt (Drug)
Outcomes
Primary Outcomes
Duration of analgesic effects in hours
Time Frame: Up to 6 hours
Secondary Outcomes
- Average severity of edema and hyperemia, assessed by investigator on a 4-point-scale(Up to day 8)
- Average number of days required to obtain remission of pain(Up to day 8)
Investigators
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